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A D Paltiel

Publications and source records attributed to A D Paltiel.

28 records · Page 2Linked to original sources
PubMed1996

The FDA and regulation of cost-effectiveness claims.

The Food and Drug Administration (FDA) has issued draft guidelines that would require more rigorous standards for making pharmacoeconomic claims. This paper critiques the guidelines and explores the objectives of market regulation for health-related cost and effectiveness information on pharmaceutical products. It argues that the FDA should proceed with caution and flexibility. In particular, regulations should recognize the potential usefulness of pharmacoeconomic information in helping health care decisionmakers make better-informed choices. They also should acknowledge the enhanced ability of those using the information to evaluate pharmacoeconomic studies and the degree to which the various players in the market can impose their own regulatory discipline.

Cost-Benefit Analysis↗
PubMed1993

The epidemiological and economic consequences of AIDS clinical trials.

The Food and Drug Administration (FDA) must manage the delicate balance between speed and safety in the evaluation and approval of new drugs. To explore how these competing obligations might be formalized with respect to the AIDS epidemic, we present a simple decision-theoretic optimization model of the clinical trials process against a backdrop of HIV transmission. Our framework sheds light on such issues as the economic consequences of decisions, the potential savings of a new therapy, the costs to society of delay, the value of better information, and how and when to undertake a clinical trial. We believe that this article represents a first effort to unravel the tangled web of epidemiological, economic, and statistical considerations that plague this policy issue.

Acquired Immunodeficiency Syndrome↗
PubMed1991

Modeling zidovudine therapy: a cost-effectiveness analysis.

Zidovudine (ZDV), the first FDA-approved therapy for HIV/AIDS, poses a dilemma to the policymaker. On the one hand, ZDV extends the life of HIV-infected persons, producing a clear benefit. On the other hand, some fear that prolonging the lives of infected individuals may contribute to the increased spread of the virus and to a steep rise in the overall costs of AIDS to society. To address this issue, we present a simple model of ZDV therapy against a backdrop of HIV transmission in a population of sexually active, gay men. We find no basis for the fear of dramatic increases in the incidence of AIDS or its associated costs among gay men due to widespread ZDV distribution. On the contrary, our analysis suggests that ZDV therapy is cost-effective, particularly when it is accompanied by modest efforts to promote behavior change and prevention.

Acquired Immunodeficiency Syndrome↗
PubMedDate not supplied

Evaluation of therapeutic strategies: a new method for balancing risk and benefit.

OBJECTIVE: A patient-specific drug safety-efficacy index was developed that combined objective clinical trial information about dose-related efficacy and toxicity with subjective perspectives on efficacy-toxicity trades. METHODS: Patient preferences were systematically assessed using the probability tradeoff technique (PTT). Toxicity ranges over which a drug's efficacy exceeded the patient's minimally acceptable efficacy represented ranges of "surplus efficacy." These can be related to the dose interval in which a drug delivers this surplus efficacy. Seventy surplus efficacy functions (for 7 hypothetical drugs and 10 hypothetical preference curves) were simulated. RESULTS: The analysis showed that index values change markedly by dose and patient preference, suggesting that different patients will benefit from different drugs depending on the dose prescribed and each patient's subjective assessment of the efficacy/toxicity tradeoff. In most situations, drugs achieve positive surplus efficacy only over limited dose ranges. The model was sensitive to different preference curves and discriminated well among drugs with different efficacy or safety profiles. CONCLUSION: This index provides a new, systematic approach to choosing a specific therapeutic intervention and dosage, when known risks and benefits are reconciled against patient-specific preferences among an array of therapeutic alternatives.

Journal Article↗
PubMedDate not supplied

Five minutes with the Governor.

This paper aims to initiate a dialog among readers regarding the positioning and promotion of health-related decision analysis in the public sector. It is motivated by the author's personal observations that quantitative and economic evaluation methods continue to be viewed with skepticism by some public officials and that no consensus exists within our community as to what an appropriate message to such decision makers might be. A personal view of some key themes to be stressed in defining a vision for the field is presented.

Cost-Benefit Analysis↗
PubMedDate not supplied

The cost-effectiveness of fluconazole prophylaxis against primary systemic fungal infections in AIDS patients.

OBJECTIVE: To project the cost-effectiveness of fluconazole for prophylaxis against AIDS-related primary systemic fungal infections. DESIGN: A Markov model with data from the literature. PATIENTS: Hypothetical cohort of 100,000 AIDS patients. INTERVENTION: No prophylaxis, and fluconazole prophylaxis beginning when a patient's CD4 count declined to below 200/mm3, below 100/mm3, or below 50/mm3. RESULTS: The no-prophylaxis policy was associated with a discounted life expectancy of 28.20 months and direct medical costs of $36,100 per person. The < 200/mm3 strategy increased costs to $40,500 and life expectancy to 28.42 months, producing a ratio of $240,000 per year of life saved (YLS). Compared with the no-prophylaxis and < 200/mm3 policies, the intermediate alternatives were less economically efficient. A reduction in fluconazole's cost from $206 to $80 decreased the ratio to $50,000 for the < 200/mm3 strategy. Doubling fungal infection incidence lowered this ratio to $96,000/YLS. CONCLUSIONS: Fluconazole prophylaxis is unlikely to be cost-effective unless its cost is lowered, or it is focused on patients in regions endemic for fungal infections.

AIDS-Related Opportunistic Infections↗
PubMedDate not supplied

Estimating CE ratios under second-order uncertainty: the mean ratio versus the ratio of means.

Two methods have been presented for estimating cost-effectiveness ratios under conditions of second-order (model) uncertainty: one method estimates a mean ratio of cost to effect (the "mean ratio" approach), and the other estimates a ratio of mean cost to mean effect (the "ratio of means" approach). However, the question of which estimate is theoretically correct has not been formally addressed. The authors show that the "ratio of means" approach follows directly from the theoretical foundations of cost-effectiveness analysis, has attractive internal consistency properties, and is consistent with a simple vector algebra approach to the problem. In contrast, the "mean ratio" approach has not been shown to follow from first principles, is internally inconsistent, and can prescribe economically inefficient choices. It is concluded that the "ratio of means" procedure should be preferred unless persuasive arguments are presented to the contrary.

Computer Simulation↗
PubMedDate not supplied

The cost-effectiveness of HIV testing: accounting for differential participation rates.

OBJECTIVE: To understand the impact of differences in participation rates between infected and uninfected individuals on estimates of the cost-effectiveness of HIV screening. METHODS: Costs per infection detected are modeled as function of both prevalence and serostatus-dependent testing rates. Data from national surveillance surveys, seroprevalence studies, and other sources are employed to suggest the magnitude of results. RESULTS: Differential participation produces a near-doubling in the estimated cost per infection identified. This result is sensitive to assumptions regarding the benefits of screening for seronegatives. CONCLUSIONS: Voluntary HIV screening programs may incur prohibitive costs by over-recruiting people at little risk of infection. Failure to account for differential participation can result in over-optimistic cost-effectiveness estimates. However, the relevance of this result--and the significance of both prevalence and participation as cost drivers--is overwhelmed by what is assumed about the benefits conferred to uninfected people by HIV screening.

Cost-Benefit Analysis↗
PubMedDate not supplied

A Monte Carlo simulation of advanced HIV disease: application to prevention of CMV infection.

BACKGROUND: Disagreement exists among decision makers regarding the allocation of limited HIV patient care resources and, specifically, the comparative value of preventing opportunistic infections in late-stage disease. METHODS: A Monte Carlo simulation framework was used to evaluate a state-transition model of the natural history of HIV illness in patients with CD4 counts below 300/mm3 and to project the costs and consequences of alternative strategies for preventing AIDS-related complications. The authors describe the model and demonstrate how it may be employed to assess the cost-effectiveness of oral ganciclovir for prevention of cytomegalovirus (CMV) infection. RESULTS: Ganciclovir prophylaxis confers an estimated additional 0.7 quality-adjusted month of life at a net cost of $10,700, implying an incremental cost-effectiveness ratio of roughly $173,000 per quality-adjusted life year gained. Sensitivity analysis reveals that this baseline result is stable over a wide range of input data estimates, including quality of life and drug efficacy, but it is sensitive to CMV incidence and drug price assumptions. CONCLUSIONS: The Monte Carlo simulation framework offers decision makers a powerful and flexible tool for evaluating choices in the realm of chronic disease patient care. The authors have used it to assess HIV-related treatment options and continue to refine it to reflect advances in defining the pathogenesis and treatment of AIDS. Compared with alternative interventions, CMV prophylaxis does not appear to be a cost-effective use of scarce HIV clinical care funds. However, targeted prevention in patients identified to be at higher risk for CMV-related disease may warrant consideration.

AIDS-Related Opportunistic Infections↗